LVAD gives cardiac patients a third choice for lifesaving treatment

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When a heart transplant or medication is not an option for patients with end-stage cardiac disease, the surgically implanted LVAD (Left Ventricular Assist Device) can be a lifesaving and life-changing essential treatment, especially as the device and how it’s used and understood continues to evolve.

Although the development of the LVAD dates to the 1960s, the Food and Drug Administration didn’t approve the first LVAD until 1994. Currently, LVADs are in their third generation with the HeartMate3 by Abbott the only one currently on the market (though some older devices are still in use by patients).

Dr. Jeffrey Alexis, MD, a heart failure cardiologist and medical director of ventricular assist devices for UR Medicine’s Advanced Heart Failure team, has had the opportunity to see the evolution of the LVAD — which he calls a “wonderful treatment for patients with end-stage heart failure”— first hand and hands-on.

After earning his M.D. from Harvard University in 1992 and completing his residency at Massachusetts General Hospital, he served as a cardiology fellow at the Mount Sinai School of Medicine. It was there he had his first real experience with the devices in the mid to late nineties.

“With the first generation of LVAD if you sat next to someone with one you definitely knew they had it because of the noise,” Alexis said. “It was that loud. Now you can sit next to someone who has one and not realize that they have it.”

The mechanical pumps were also large and could only be implanted in bigger patients, said Alexis, who explained device size has improved with each generation, as have other issues.

“One of the great things is that survival continues to improve from the earliest version of the device,” Alexis said. “In the beginning, it was uncommon for a patient to survive one year, let alone two years. Now in our program, we have patients who have up to around fifteen years of LVAD support. The survival is improving as devices improve.”

URMC’s LVAD program, which is one of the largest in the country, was created in 2001 and has played a vital role in clinical studies for each generation of the devices.

In 2018, URMC pioneered a less invasive surgical technique for implanting the HeartMate3 called the sternal-sparing implant technique. Approved by the FDA in 2019, it helps patients recover more easily and quickly and has allowed the device to be used in smaller people, Alexis explained.

With this technique — developed by Igor Gosev, M.D., Ph.D. and performed for the first time at Strong Memorial Hospital — surgeons attach the HeartMate 3 to the heart using two small incisions, avoiding the need to open the sternum.

URMC was also part of a study released in November 2023 called ARIES-HM3 that showed an aspirin-free regimen can improve outcomes for people living with a heart pump by lowering hospitalizations without increasing the risk of blood clots.

“Patients have traditionally been on aspirin because clotting and bleeding are the big fears of the machine, especially clotting,” Alexis said. “But what we found is that bleeding is also a problem and somewhat exacerbated by some of the medications we give to prevent clotting. So, in a recent study, we now see that when we put the LVAD in, patients don’t need to be on aspirin. It’s an important finding.”

Dr. Lisa Harris, M.D., senior vice president and chief medical officer at Excellus BlueCross BlueShield says LVADs have been a life-changing solution for people with a history of heart failure. She explained they can be both a bridge to transplant — helping a patient survive until a heart for transplant is found or a destination therapy — for patients with heart failure who aren’t candidates for heart transplant surgery or prefer not to have a transplant.

“The bottom line is that before the LVAD we only had transplant or medicine,” Harris  said. “They have become a life-changing solution. Not only have they been able to extend life but [also] improve quality of life.”

Harris notes that it is important to remember, though, that having an LVAD implanted remains a “significant surgery” that is not common, even though it is becoming more common than it has in the past.

For Dr. Scott C. Feitell, DO, director of heart failure at Rochester Regional Health’s Sands-Constellation Heart Institute and director of the cardiac intensive care unit at Rochester General Hospital, the “Holy Grail” of next generation of the LVAD would be an internal battery.

“Right now, patients need to have an internal pump and a wire has to come out of their stomach that we tunnel out that’s connected to batteries,” Feitell said. “I’m ever the optimist. I’ve got hope that in the near future perhaps we’ll see a fully implantable pump that doesn’t have any external wire.”

Feitell was first exposed to LVADs as a third-year med student at the Philadelphia College of Osteopathic Medicine when he observed one being implanted into a patient he was helping care for.

“This patient was at death’s door,” Feitell recalled. “And we had this big discussion and I still remember that conversation. The patient got approved and I was still on the rotation when the patient got to go home. I just couldn’t believe what I’d seen with my own eyes. The fire was lit.”

Following his fellowship at the Cleveland Clinic, Feitell came to RRH seven and a half years ago to help establish their program. The program achieved its first implant in November 2018 (that patient continues to do well) and has grown to five physicians and a dedicated team of nurses and advanced practice providers.

“Our team’s grown exponentially and we’re one of the largest destination therapy programs in the country,” said Feitell, who noted RRH performed 37 LVADs on adults last year, which is on the higher end of volume for programs nationwide.

Having seen how LVADs not only save lives but improve a patient’s quality of life, Feitell believes it’s important to make the device as accessible as possible to those who need it by identifying them sooner and referring them appropriately.

“Even in the modern era, we still meet patients very, very late,” Feitell said. “There are over 5,000 hospitals in the U. S. and only 120 of them implant LVADs. Sometimes patients get referred to us very late and we have missed opportunities, so I think that’s one area where we can certainly as a country expand the patient population that can benefit from this therapy.”

Caurie Putnam is a Rochester-area freelance writer.